Marketing Authorization Holders (MAH) in Estonia involved in medicines/medicinal products and medical devices are expected to develop and implement a full pharmacovigilance approach for the Estonian market in accordance with the relevant EU legislation.
The MAH is expected to work closely with the Pharmacovigilance Centre (within the State Agency of Medicines (SAM)) to manage the data generated from pharmacovigilance activities. Regular reporting and transfer of information is required.
Collaboration is evident between the regulatory agencies in the Baltic States, and agreement has been reached, for example, with regard to GMP, GDP and pharmacovigilance inspections. Further change in the administrative processes associated with local pharmacovigilance is likely as a result. This should be to the benefit of those working in one or (more particularly) more than one of the Baltic States. Monitoring and planning for change is vital.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
National legislation allows for the qualified person responsible for pharmacovigilance activities (QPPV) in Estonia to be resident outside the country (although they must be resident within the EU). However, the MAH must appoint an Estonian-speaking contact person. This contact person will have specific responsibility for the provision of information to prescribers with regard to any safety risks associated with the use of medicines.
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in the Estonian market within a fully comprehensive outsourced local pharmacovigilance solution.
A FULLY COMPREHENSIVE SOLUTION FOR LOCAL PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant local authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in medicines/medicinal products and medical devices, the pharmacovigilance service package comprises:
- Full-time (24/7) service of a local qualified pharmacovigilance person, QPPV
- 24-hour cover for adverse event reporting
- In-time case reporting
- End-to-end processing of safety information
- Production of PSUR (periodic safety update reports)
- Production of individual case study reports
- Access, as and when appropriate, to local healthcare professionals and authorities
- MLM (Medical Literature Monitoring services)
- System quality control checks to ensure full audit compliance